Documents and Downloads
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Study Documentation (11)
Protocol (2)
Protocol - v 16 - last updated 17 October 2007
SPIRIT Protocol - v15 - last updated 14 June 2006
PIL/IC Form (3)
PIL/IC Form - v3 - last updated 17 October 2007
PIL/IC Form - v2 - last updated 08 January 2007
PIL/IC Form - v1 - last updated 20 July 2004
GP Letter (2)
GP Letter - v1 - last updated 26 March 2004
GP Letter - v2 - last updated 17 October 2007
SAE Form (1)
SAE Form - v3 - last updated 12 January 2009
Site Delegation Log (2)
Site Delegation Log - v1 - last updated 13 June 2005
Site Delegation Log - v2 - last updated 05 June 2006
Participant Log (1)
Participant Log - v1 - last updated 13 June 2005
Screening Log (1)
Screening Log - v1 - last updated 13 June 2005
Patient Booklet - How to take your study medication (2)
Patient Booklet - How to take your study medication - v1 - last updated 08 January 2007
Patient Booklet - How to take your study medication - v2 - last updated 24 October 2007
Document Version Control List - last updated 13 January 2011
This document lists the version control history of documents in use on the SPIRIT 1 Trial.
Site Laboratory Normals Form - v1 - last updated 13 June 2005
eCRF completion guidelines - last updated 28 March 2008
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Pharmacy (7)
IB (PEG Interferon alpha-2a) ( Private category, login required. )
Pharmacy manual - v7.0 - last updated 10 June 2009
Prescription - Arm A - 400mg Imatinib - v2 - last updated 19 January 2006
Prescription - Arm B - 800mg Imatinib - v2 - last updated 19 January 2006
Prescription - Arm C - 400mg Imatinib + Pegasys - v3 - last updated 08 January 2007
Dispensing and Returns Log - v2 - last updated 30 May 2006
Drug receipt log - v2 - last updated 30 May 2006
MHRA (12)
Imatinib DDX - last updated 16 March 2004
Peginterferon alpha-2a DDX - last updated 02 January 2004
MHRA confirmation of DDX rollover to CTA - last updated 21 April 2004
Conversion of DDX exemptions to Clinical Trial Authorisation
Amendment 1 - Substantial Amendment Notification - signed - last updated 14 July 2006
Amendment 1 - MHRA Approval - last updated 14 September 2006
Also includes MREC approval dated 01 Sept 06
Amendment 2 - Cover letter to MHRA - last updated 20 November 2007
Amendment 2 - Substantial Amendment Notification - unsigned - last updated 17 October 2007
Amendment 2 - MHRA Approval - last updated 09 January 2008
Amendment Planned Cessation of Recruitment Dec08 - Cover letter to MHRA - last updated 19 December 2008
Amendment Planned Cessation of Recruitment Dec08 - Substantial amendment notification - last updated 19 December 2008
Amendment Planned Cessation of Recruitment Dec08 - MHRA Approval - last updated 07 January 2009
Response to comment in MHRA Notification Amendment 2 - last updated
Ethics (10)
MREC application form - unsigned - last updated 26 March 2004
MREC application form - signature page - last updated 26 March 2004
MREC approval - last updated 20 August 2004
Amendment 1 - substantial amendment notification - last updated 08 January 2007
Amendment 1 - MREC approval - last updated 15 January 2007
Amendment 2 - substantial amendment notification - last updated
Amendment 2 - MREC approval - last updated 12 November 2007
Amendment Planned Cessation of Recruitment Dec08 - main REC cover letter - last updated 19 December 2008
Amendment Planned Cessation of Recruitment Dec08 - Substantial amendment notification - last updated 19 December 2008
Amendment Planned Cessation of Recruitment Dec08 - main REC response - last updated 06 January 2009
Sponsor (2)
Letter of Sponsorship - last updated 18 February 2004
Sponsor Indemnity - last updated 09 March 2004
Presentations (4)
NCRI CML WG presentation May 2008 - last updated
NCRI CML Working Group presentation given at Annual Review of Leukaemia meeting in May 2008. Includes preliminary high-level results from SPIRIT 1 study and an overview of the SPIRIT 2 Study.
Site Initiation Presentation - last updated 12 November 2008
SPIRIT Presentation from CML Conference 17 Nov 2008 - last updated
SPIRIT Presentation CML Conference Cambridge - last updated
Patients (0)
Safety Reports (2)
SUSARs (PEG Interferon alpha-2a) ( Private category, login required. )
SPIRIT Annual Safety Report 2009-10 - last updated 04 February 2010